Orange Book product · Generic (ANDA)
SULFAMETHOXAZOLE AND TRIMETHOPRIM
SULFAMETHOXAZOLE; TRIMETHOPRIM
At a glance
Feb 08, 2022
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 08, 2022
4 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
SULFAMETHOXAZOLE; TRIMETHOPRIM
Strength
200MG/5ML;40MG/5ML
Dosage form
SUSPENSION
Route
ORAL
TE code
AB
Application
ANDA 214330
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of SULFAMETHOXAZOLE; TRIMETHOPRIM
- 1984SULFAMETHOXAZOLE AND TRIMETHOPRIMBrand (NDA)
NDA 018946 · HEATHER
- 1983SULFAMETHOXAZOLE AND TRIMETHOPRIMBrand (NDA)
NDA 018812 · TEVA
- 1983SULFATRIMBrand (NDA)
NDA 018615 · PHARM ASSOC
- 1982SULFAMETHOXAZOLE AND TRIMETHOPRIMBrand (NDA)
NDA 018598 · FOSUN PHARMA
- —BACTRIMBrand (NDA)
NDA 018374 · SUN PHARM INDS INC
- —SEPTRABrand (NDA)
NDA 018452 · MONARCH PHARMS
- —BACTRIMBrand (NDA)
NDA 017560 · SUN PHARM INDUSTRIES
- —SEPTRABrand (NDA)
NDA 017598 · MONARCH PHARMS
- —BACTRIMBrand (NDA)
NDA 017377 · SUN PHARM INDUSTRIES
- —SEPTRABrand (NDA)
NDA 017376 · MONARCH PHARMS
- —SULFAMETHOXAZOLE AND TRIMETHOPRIMBrand (NDA)
NDA 018242 · TEVA
- 2021SULFAMETHOXAZOLE AND TRIMETHOPRIMGeneric (ANDA)
ANDA 212699 · LUPIN
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

